A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of PTSD according to the DSM-5
• Subjects who are within 1 to 20 years since index trauma
Locations
Other Locations
Japan
Heart Care Clinic Omachi
RECRUITING
Akita
Aburayama Hospital
RECRUITING
Fukuoka
Ai Sakura Clinic
RECRUITING
Fukuoka
Hatakeyama Clinic
RECRUITING
Fukuoka
Hiro Mental Clinic
RECRUITING
Fukuoka
Hirota Clinic
RECRUITING
Fukuoka
Kurume University Hospital
RECRUITING
Fukuoka
Medical corporation Shinseikai Kaku Mental Clinic
RECRUITING
Fukuoka
Mental Clinic Sakurazaka
RECRUITING
Fukuoka
Nishie Kokorono Clinic
RECRUITING
Fukuoka
Uematsu Mental Clinic
RECRUITING
Fukuoka
PTSD Care Matsumoto Mental Clinic
RECRUITING
Gunma
Goryokai Hospital
RECRUITING
Hokkaido
Sakamoto Misako Mental Clinic
RECRUITING
Hyōgo
Takahashi Psychiatric Clinic
RECRUITING
Hyōgo
Tsukuba Psychosomatics Clinic
RECRUITING
Ibaraki
Musashikosugi J Kokorono Clinic
RECRUITING
Kanagawa
Niki Hearty Hospital
RECRUITING
Kumamoto
Arata Clinic
RECRUITING
Nagasaki
Okayama Psychiatric Medical Center
RECRUITING
Okayama
Barclay Imuro Mental Clinic
RECRUITING
Okinawa
Medical Corporation Mikokorokai Shimizu Clinic
RECRUITING
Osaka
Sho Midori Hospital
RECRUITING
Saitama
Ai Mental Clinic
RECRUITING
Tochigi
i Kokoro Clinic Nihonbashi
RECRUITING
Tokyo
Iidabashi Mental Clinic
RECRUITING
Tokyo
Ikebukuro Olive Mental Clinic
RECRUITING
Tokyo
Kitaikebukuro Kokoro No Clinic
RECRUITING
Tokyo
Maynds Tower Mental Clinic
RECRUITING
Tokyo
Monzennakacho Mental Clinic
RECRUITING
Tokyo
Nippon Medical School Hospital
RECRUITING
Tokyo
Sakurazaka Clinic SophyAnce
RECRUITING
Tokyo
Sangenjaya Nakamura Mental Clinic
RECRUITING
Tokyo
Wakamatsucho Kokoro to Hifu Clinic
RECRUITING
Tokyo
Yamanashi Prefectural Kita Hospital
RECRUITING
Yamanashi
Contact Information
Primary
Kentaro Ishinabe
OtsukaRegistry-CT@otsuka.jp
+81-3-6361-7459
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 52
Treatments
Experimental: The Software as a Medical Device1
Other: The Software as a Medical Device2
Related Therapeutic Areas
Sponsors
Leads: Otsuka Medical Devices Co., Ltd. Japan
Collaborators: Otsuka Pharmaceutical Co., Ltd.